BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP COVER ACCESSORY

    MDR report key: 3092663 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01533
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP 1- ADDITIONAL INFORMATION: ON (B)(4) 2013, AN INTUITIVE SURGICAL REPRESENTATIVE SPOKE WITH THE SITE'S ROBOTICS COORDINATOR. SHE REPORTED THAT THE DAMAGED TIP COVER WAS ACTUALLY DISCOVERED WHEN THE INSTRUMENT WAS BEING REMOVED FROM THE PATIENT. THE SURGICAL STAFF DID NOT NOTICE ANY ARCING EVENTS DURING THE DA VINCI SI HYSTERECTOMY SURGICAL PROCEDURE AND CONFIRMED THERE WAS NO PATIENT HARM DURING AND AFTER THE SURGICAL PROCEDURE. SHE WAS UNABLE TO OBTAIN ANY OTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE ALLEGED COMPLAINT. VISUAL INSPECTION OF THE TIP COVER SHOWED A COUPLE OF TEARS ON ONE SIDE OF THE COMBINED SILICONE/PELLETHANE SECTION. TEARS WERE ROUGHLY 0.050 LONG, LOCATED AROUND 0.430 BELOW THE DISTAL END OPENING. TEARS DID NOT GO THROUGH THE ENTIRE WALL THICKNESS OF THE SECTION. ADDITIONAL OBSERVATION THAT WAS NOT INITIALLY REPORTED BY THE CUSTOMER WAS ARCING DAMAGE. THE COMBINED SILICONE/PELLETHANE SECTION HAD A HOLE BURNED THOUGH IT. THE HOLE EXHIBITED LOCALIZED MELTING, INDICATIVE OF ARCING. THE HOLE MEASURED ROUGHLY 0.035 X 0.015 AND WAS LOCATED 0.600 BELOW THE DISTAL END OF THE TIP COVER. ONE EDGE OF THE HOLE APPEARED TO HAVE A TEAR. ON (B)(4) 2013, INTUITIVE SURGICAL (ISI) SPOKE WITH THE USER SITE'S ROBOTICS COORDINATOR. SHE WAS UNABLE TO PROVIDE INFORMATION ABOUT WHAT EVENTS LED TO THE DAMAGED TIP COVER AT THE TIME OF THE CALL. ISI MADE SEVERAL ADDITIONAL ATTEMPTS TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAD BEEN UNABLE TO REACH THE ROBOTICS COORDINATOR. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING A DA VINCI S SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED SLITS ON THE TIP COVER USED WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THE REPORTER STATED THAT THE TIP COVER INSTALLATION TOOL WAS USED WHEN INSTALLING THE TIP COVER AND THAT THE TIP COVER WAS INSPECTED PRIOR TO USE. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193652 TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12 M10121205

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES, ESU